Drug delivery customized ear canal apparatus

ABSTRACT

The present invention is directed to a wearable system wherein elements of the system, including various sensors adapted to detect biometric and other data and/or to deliver drugs, are positioned proximal to, on or in the ear canal of a person. In embodiments of the invention, elements of the system, including drug delivery devices, are positioned on or in the ear canal for extended periods of time. For example, an element of the system may be positioned on the tympanic membrane of a user and left there overnight, for multiple days, months, or years. Because of the position and longevity of the system elements in the ear canal, the present invention has many advantages over prior wearable biometric and drug delivery devices.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/282,809, filed Sep. 30, 2019; which claims the benefit of U.S.Provisional Application Nos. 62/236,295, filed Oct. 2, 2015; and62/395,667, filed Sep. 16, 2016; which are incorporated herein byreference in their entirety.

BACKGROUND OF THE INVENTION

The present invention is related to wearable devices and methods fortheir use. The present invention is further related to hearing devices.The present invention is further related to drug delivery devices. Thepresent invention is further related to methods for the use of wearabledevices, hearing devices and drug delivery devices.

SUMMARY OF THE INVENTION

The present invention is directed to a wearable system wherein elementsof the system, including various sensors, are adapted to detectbiometric and other data and/or to deliver drugs. In this invention, theelements of the system are positioned proximal to, on, or in the earcanal of a person. In embodiments of the invention, elements of thesystem are positioned external to, on or in the ear canal and may residethere for extended periods of time. For example, an element of thesystem, including drug delivery devices, may be positioned on thetympanic membrane of a user and left there overnight, for multiple days,months or years. Because of the position and longevity of the systemelements in the ear canal, the present invention has many advantagesover prior drug delivery devices.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of embodimentsof the present inventive concepts will be apparent from the moreparticular description of preferred embodiments, as illustrated in theaccompanying drawings in which like reference characters refer to thesame or like elements. The drawings are not necessarily to scale;emphasis instead being placed upon illustrating the principles of thepreferred embodiments.

FIG. 1 shows a hearing system configured in accordance with embodimentsof the present invention.

FIG. 2 shows an isometric view of the medial ear canal assembly of thehearing system of FIG. 1 in accordance with embodiments of the presentinvention.

FIG. 3 shows a top view of the medial ear canal assembly of the hearingsystem of FIG. 1 in accordance with embodiments of the presentinvention.

FIG. 4 shows an exploded view of a medial ear canal assembly and itsmethod of assembly, in accordance with embodiments of the presentinvention.

FIG. 5A is an isometric Top view of a medial ear canal assembly inaccordance with embodiments of the present invention.

FIG. 5B is an isometric bottom view of a medial ear canal assembly inaccordance with embodiments of the present invention.

FIG. 6 shows a medial ear canal assembly in accordance with embodimentsof the present invention.

FIG. 7 shows an isometric view of a medial ear canal assembly includinga drug delivery reservoir in accordance with embodiments of the presentinvention.

FIG. 7A is a side view of a medial ear canal assembly including drugdelivery system according to one embodiment of the invention.

FIG. 8 shows an isometric view of a lateral ear canal assembly inaccordance with embodiments of the present invention.

FIG. 9 is an isometric top view of a medial ear canal assembly inaccordance with embodiments of the present invention.

FIG. 10 is an isometric bottom view of a medial ear canal assembly inaccordance with embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION Advantages

In embodiments of the present invention, biometric sensors and otherdevices may be placed in proximity to, on or in the ear canal resultingin a system with the ability to collect information on the user'senvironment, including information on the user's location, the time ofday, and the activity the user is engaged in. In embodiments of thepresent invention, drug delivery devices may be placed in proximity to,on or in the ear canal resulting in a system with the ability to deliverdrugs to a user through the ear and/or components of the ear. Inembodiments of the present invention, the combination of a superiorhearing system with biometric sensors and other devices, such as drugdelivery devices, in a single system which may be placed in proximityto, on or in the ear canal may result in a system with the ability tocollect information on the user's environment, including information onthe user's location, the time of day, and the activity the user isengaged in. The system may further provide access to highly vascularsections of ear canal, including the pars tensa and manubrium vesselsand the information that may be gathered from such locations.

The system may further provide the ability to gather data, monitorhealth, send alerts and deliver drugs through a device that is in place24 hours a day for years on end, without interfering with or changingthe wearer's day to day activities. The system may further provide theability to ensure user compliance without the need for user interaction,other than, in some cases, normal upkeep. In some embodiments, thecurrent invention may be used to replace halter monitors, eventrecorders and/or Sub-Cutaneous (Sub-Q) monitors (e.g. injectablemonitors). The system may further provide the ability to mount sensorsdirectly against the skin and ensure that they stay in place over longperiods of time, by, for example, using system components that arecustom fit to the ear canal wall and/or to the tympanic membrane. Thesystem may further provide the user with feedback, instructions orwarnings which go directly to the wearer's tympanic membrane in a mannerwhich is imperceptible to any third party.

A system according to the present invention may further enable a user totake advantage of characteristics of the ear canal of the user to makemeasurements of the user's biometric data, including: positioning ofsensors in a place, which is undetectable to both the user and thirdparties; positioning of sensors in a place where they are well protectedfrom the environment, and from external forces (not subject to falsealarms, such as, for example, the type of false alarms that result fromthe dropping or shaking of externally worn devices); positioning ofsensors in a very vascular environment; positioning sensors in anenvironment which may be highly conducive to the measurement ofbiometric data (an environment where a better signal to noise ratio isachievable—enclosed and dark to facilitate optical measurements; andpositioning sensors in an environment where an extensive range ofbiometric data is available and can be measured, including bloodpressure, heart rate, glucose levels, respiration rate, temperature,blood flow and other biometric data.

A system according to the present invention may further provide: theability to deliver drugs to a user, including sustained, timed and/oralgorithm controlled drug delivery; the ability to ensure compliancewith drug regimens by automating drug delivery in an easily accessibleregion such as the ear canal; the ability to limit the amount of drugdelivered without compromising efficacy by delivering to highly vasculartissue in or around the ear canal, such as, for example, the pars tensaand manubrium vessels; the ability to deliver drugs to regions of thebody where the vasculature is easily accessible, for example, where thetissue covering the vasculature is very thin, such as, for example, overthe manubrium vessels; the ability to locally deliver drugs which arenormally delivered systemically, thereby reducing the amount of drugsdelivered and the related side effects; and the ability to deliver drugsand treat diseases using a novel platform in the ear canal. Drugs whichmay be delivered using the present invention include antibiotics(neomycin/quinolenes), dexamethasone, steroids (prednisolone), aceticacid, aluminum acetate, boric acid, betnesol, prednisolone sodiumphosphate, clotrimazole, Ceruminolytic agents (sodiumchloride/chlorbutanol/paradichlorobenzene), amoxicillin, flucloxacillin;ciprofloxacillin, penicillin, betahistine dopamine antagonists(prochlorperazine), antihistamines (cinnarizine and cyclizine),antiviral drugs (acyclovir), sodium fluoride, nicotine and insulin.Diseases which may be treated using the present invention include acuteotitis media, furunculosis of external auditory canal, perichondritis ofpinna, acute mastoiditis, and malignant otitis externa, vertigo, herpeszoster oticus and cancer. Embodiments of the invention may be used todeliver drugs in which systemic or local drug delivery would bebeneficial.

FIG. 1 shows a hearing system 10 configured to transmit electromagneticenergy EM to a medial ear canal assembly 100 positioned in the ear canalEC of the user. The ear comprises an external ear, a middle ear ME andan inner ear. The external ear comprises a Pinna P and an ear canal ECand is bounded medially by a tympanic membrane (also referred to as aneardrum) TM. Ear canal EC extends medially from pinna P to tympanicmembrane TM. Ear canal EC is at least partially defined by a skin SKdisposed along the surface of the ear canal. The tympanic membrane TMcomprises a tympanic membrane annulus TMA that extends circumferentiallyaround a majority of the eardrum to hold the eardrum in place. Themiddle ear ME is disposed between tympanic membrane TM of the ear and acochlea CO of the ear. The middle ear ME comprises the ossicles OS tocouple the tympanic membrane TM to cochlea CO. The ossicles OS comprisean incus IN, a malleus ML and a stapes ST. The malleus ML is connectedto the tympanic membrane TM and the stapes ST is connected to an ovalwindow OW, with the incus IN disposed between the malleus ML and stapesST. Stapes ST is coupled to the oval window OW so as to conduct soundfrom the middle ear to the cochlea.

The hearing system 10 may include an input transducer assembly 20 and amedial ear canal assembly 100 to transmit sound to the user. Hearingsystem 10 may comprise a sound processor 24, which may be, for example,a behind the ear unit (BTE). Sound processor 24 may comprise manycomponents of hearing system 10 such as a speech processor, battery,wireless transmission circuitry, and input transducer assembly 20. Theinput transducer assembly 20 can be located at least partially behindthe pinna P or substantially or entirely within the ear canal EC. Inputtransducer assembly 20 may further comprise a Bluetooth™ connection tocouple to a cell phone or other external communication device 26. Themedial ear canal assembly 100 of hearing system 10 may comprisecomponents to receive the light energy or other energy, such as RFenergy and vibrate the eardrum in response to such energy.

The input transducer assembly 20 can receive a sound input, for examplean audio sound or an input from external communication device 26. Withhearing aids for hearing impaired individuals, the input can be ambientsound. The input transducer assembly may comprise at least one inputtransducer, for example a microphone 22. The at least one inputtransducer may comprise a second microphone located away from the firstmicrophone, in the ear canal or the ear canal opening, for examplepositioned on sound processor 24. Input transducer assembly 20 may alsoinclude can include a suitable amplifier or other electronic interface.In some embodiments, the input may comprise an electronic sound signalfrom a sound producing or receiving device, such as a telephone, acellular telephone, a Bluetooth connection, a radio, a digital audiounit, and the like.

Input transducer assembly 20 may include a lateral ear canal assembly 12which may comprise a light source such as an LED or a laser diode fortransmitting data (including audio data) and energy to medial ear canalassembly 100. In other embodiments, lateral ear canal assembly 12 maycomprise an electromagnetic coil, an RF source, or the like fortransmitting data (including audio data) and energy to medial ear canalassembly 100. In embodiments of the invention, lateral ear canalassembly 12 may further comprise a receiver adapted to receive datatransmitted from medial ear canal assembly 100, such as, for example,biometric data from sensors positioned on or near medial ear canalassembly 100.

In embodiments of the invention, medial ear canal assembly 100 isadapted to receive the output from input transducer assembly 20 andproduce mechanical vibrations in response to the received information,which may be, for example, in the form of a light signal generated bylateral ear canal assembly 12. In embodiments of the invention, medialear canal assembly 100 comprises a sound transducer, wherein the soundtransducer may comprise at least one of a microactuator, a coil, amagnet, a magnetostrictive element, a photostrictive element, or apiezoelectric element. In embodiments of the invention, input transducerassembly 20 may comprise a light source coupled to sound processor 24 bya fiber optic cable and positioned on lateral ear canal assembly 12. Inembodiments of the invention, input transducer assembly 20 may comprisea laser diode coupled to sound processor 24 and positioned on lateralear canal assembly 12. In embodiments of the invention, the light sourceof the input transducer assembly 20 may be positioned in the ear canalalong with sound processor 24 and microphone 22. When properly coupledto the subject's hearing transduction pathway, the mechanical vibrationscaused by medial ear canal assembly 100 can stimulate the cochlea CO,which induces neural impulses in the subject which can be interpreted bythe subject as a sound input.

FIG. 2 and FIG. 3 show isometric and top views, respectively, of anembodiment of medial ear canal assembly 100 according to the presentinvention. In the illustrated embodiments, medial ear canal assembly 100may comprise a retention structure 110, a support structure 120, atransducer 130, at least one spring 140, and a photodetector 150. Medialear canal assembly 100 may include data processor 200 and transmitter210 which may be positioned on transducer 130. Retention structure 110,which may be a resilient retention structure, may be sized to couple tothe tympanic membrane annulus TMA and at least a portion of the anteriorsulcus AS of the ear canal EC. Retention structure 110 may comprise anaperture 110A. Aperture 110A is sized to receive transducer 130 and toallow for normal transduction of sound through the subjects hearingtransduction pathway.

The retention structure 110 can be sized to the user and may compriseone or more of an O-ring, a C-ring, a molded structure, or a structurehaving a shape profile so as to correspond to the user's ear canalanatomy, or to a mold of the ear canal of the user. Retention structure110 may comprise a resilient retention structure such that the retentionstructure can be compressed radially inward as indicated by arrows 102from an expanded wide profile configuration to a narrow profileconfiguration when passing through the ear canal and subsequently expandto the wide profile configuration when placed on one or more of theeardrum, the eardrum annulus, or the skin of the ear canal. Theretention structure 110 may comprise a shape profile corresponding toanatomical structures that define the ear canal. For example, theretention structure 110 may comprise a first end 112 corresponding to ashape profile of the anterior sulcus AS of the ear canal and theanterior portion of the tympanic membrane annulus TMA. The first end 112may comprise an end portion having a convex shape profile, for example anose, so as to fit the anterior sulcus and so as to facilitateadvancement of the first end 112 into the anterior sulcus. The retentionstructure 110 may comprise a second end 114 having a shape profilecorresponding to the posterior portion of tympanic membrane annulus TMA.

The support structure 120 may be positioned in aperture 110A and maycomprise a frame, or chassis, so as to support the components connectedto support structure 120. Support structure 120 may comprise a rigidmaterial and can be coupled to the retention structure 110, thetransducer 130, the at least one spring 140, which may supporttransducer 130, and the photodetector 150. The support structure 120 maycomprise an elastomeric bumpers 122 extending between the support andthe retention structure, so as to couple the support to the retentionstructure 110 with the elastomeric bumpers 122. The support structure120 may define an aperture 120A formed thereon. The aperture 120A can besized so as to receive transducer 130, which may be, for example, abalanced armature transducer. When positioned in aperture 120A, housing139 of the balanced armature transducer 130 may extend at leastpartially through the aperture 120A when transducer 130 is coupled tothe tympanic membrane TM. Aperture 120A may be further sized to allownormal sound conduction through medial ear canal assembly 100.

Transducer 130 may, in embodiments of the invention, comprise structuresto couple to the eardrum when the retention structure 110 contacts oneor more of the eardrum, the eardrum annulus, or the skin of the earcanal. The transducer 130 may, in embodiments of the invention, comprisea balanced armature transducer having a housing 139 and a vibratory reed132 extending out one end of housing 139. Housing 139 may also, inembodiments of the invention, be a part of a flux return path fortransducer 130. In embodiments of the invention, the housing may be afully integrated part of the transducer, including, for example, themagnetic flux path. The vibratory reed 132 may be affixed to a post 134and an umbo pad 136. The umbo pad 136 may have a convex surface thatcontacts the tympanic membrane TM and may move the TM in response tosignals received by medial ear canal assembly 100, causing the TM tovibrate. The umbo pad 136 can be anatomically customized to the anatomyof the ear of the user.

At least one spring 140 may be connected to the support structure 120and the transducer 130, so as to support the transducer 130 in aperture120A. The at least one spring 140 may comprise a first spring 142 and asecond spring 144, in which each spring is connected to opposing sidesof a first end of transducer 130. The springs may comprise coil springshaving a first end attached to support structure 120 and a second endattached to transducer 130 or a mount affixed to transducer 130, suchthat the coil springs pivot the transducer about axes 140A of the coilsof the coil springs and resiliently urge the transducer toward theeardrum when retention structure 110 contacts one or more of theeardrum, the eardrum annulus, or the skin of the ear canal. The supportstructure 120 may comprise a tube sized to receiving an end of the atleast one spring 140, so as to couple the at least one spring to supportstructure 120.

In embodiments of the invention, a photodetector 150 may be coupled tosupport structure 120 of medial ear canal assembly 100. A bracket mount152 can extend substantially around photodetector 150. An arm 154 mayextend between support structure 120 and bracket mount 152 so as tosupport photodetector 150 with an orientation relative to supportstructure 120 when placed in the ear canal EC. The arm 154 may comprisea ball portion so as to couple to support structure 120 with a balljoint 128. The photodetector 150 may be electrically coupled totransducer 130 so as to drive transducer 130 with electrical energy inresponse to the light energy signal radiated to medial ear canalassembly 100 by input transducer assembly 20. In embodiments of theinvention, medial ear canal assembly 100 may include an electronicspackage 215 mounted on a back surface of photodetector 150. Electronicsin electronics package 215 may be used to, for example, condition ormodulate the light energy signal between photodetector 150 andtransducer 130. Electronics package 215 may comprise, for example, anamplifier to amplify the signal from photodetector 150.

Resilient retention structure 110 can be resiliently deformed wheninserted into the ear canal EC. The retention structure 110 can becompressed radially inward along the pivot axes 140A of the coil springssuch that the retention structure 110 is compressed as indicated byarrows 102 from a wide profile configuration having a first width 110W1as illustrated in FIG. 3 to an elongate narrow profile configurationhaving a second width 110W2. Compression of retention structure 110 mayfacilitate advancement of medial ear canal assembly 12 through ear canalEC in the direction illustrate by arrow 104 in FIG. 2 and when removedfrom the ear canal in the direction illustrated by arrow 106 in FIG. 2.The elongate narrow profile configuration may comprise an elongatedimension extending along an elongate axis corresponding to an elongatedimension of support structure 120 (120W) and aperture 120A. Theelongate narrow profile configuration may comprise a shorter dimensioncorresponding to a width of the support structure 120 and aperture 120A.The retention structure 110 and support structure 120 may be passedthrough the ear canal EC for placement on, for example, the tympanicmembrane TM of a user. To facilitate placement, vibratory reed 132 ofthe transducer 130 can be aligned substantially with the ear canal ECwhile medial ear canal assembly 100 is advanced along the ear canal ECin the elongate narrow profile configuration having second width 110W2.

When properly positioned, retention structure 110 may return to a shapeconforming to the ear canal adjacent to tympanic membrane TM, whereinthe medial ear canal assembly is held in place, at least in part, by theinteraction of retention structure 110 with the walls of ear canal EC.The medial ear canal assembly 100, including support structure 120, mayapply a predetermined amount of force to the tympanic membrane TM whenthe umbo pad 136 is in contact with the eardrum. When medial ear canalassembly 100 is positioned the support structure 120 can maintain asubstantially fixed shape and contact with the tympanic membrane TM ismaintained, at least in part, by the force exerted by at least onespring 140.

FIG. 4 is an exploded view of a medial ear canal assembly 100 accordingto embodiments of the present invention which shows an assembly drawingand a method of assembling medial ear canal assembly 100. The retentionstructure 110 as described herein can be coupled to the supportstructure 120, for example, with elastomeric bumpers 122 extendingbetween the retention structure 110 and the support structure 120. Theretention structure 110 may define an aperture 110A having a width 110AWcorresponding to the wide profile configuration. The support structure120 may define an aperture 120A having a width 120AW that remainssubstantially fixed when the resilient retention structure iscompressed. The aperture 110A of the resilient retention structure canbe aligned with the aperture 120A of the support. Support structure 120may comprise ball joint 128, and ball joint 128 can be coupled to arm154 and bracket mount 152, such that the support is coupled to thephotodetector 150.

The transducer 130 may comprise a housing 139 and a mount 138 attachedto housing 139, in which the mount 138 is shaped to receive the at leastone spring 140. The transducer 130 may comprise a vibratory reed 132extending from housing 139, in which the vibratory reed 132 is attachedto a post 134. The post 134 can be connected to the umbo pad 136.

The support structure 120 can be coupled to the transducer 130 with theat least one spring 140 extending between the coil and the transducersuch that the umbo pad 136 is urged against the tympanic membrane TMwhen the medial ear canal assembly 100 is placed to transmit sound tothe user. The support structure 120 may comprise mounts 126, for exampletubes, and the mounts 126 can be coupled to a first end of the at leastone spring 140, and a second end of the at least one spring 140 can becoupled to the transducer 130 such that the at least one spring 140extends between the support and the transducer. Umbo sensor 220 may beattached to umbo pad 136 such that umbo sensor 220 is positioned againsttympanic membrane TM when medial ear canal assembly 100 is positioned inthe ear canal. Umbo sensor may be positioned against any portion of thetympanic membrane and may be referred to as a tympanic membrane sensor.

FIG. 5A is an isometric top view of a medial ear canal assembly 100according to embodiments of the invention. FIG. 5B is an isometricbottom view of a medial ear canal assembly 100 according to embodimentsof the invention. In FIGS. 5A and 5B, medial ear canal assembly 100 hasa retention structure 110 comprising a stiff support 121 extending alonga portion of retention structure 110. The stiff support 121 may beconnected to resilient member 141 and coupled to intermediate portion149. In many embodiments, resilient member 141 and stiff supportstructure 120 comprise an integrated component such as an injectionmolded (or 3-D Printed) unitary component comprising a modulus ofelasticity and dimensions so as to provide the resilient member 141 andthe stiff support 121.

In the embodiments of FIG. 5A and 5B, stiff support 121 and resilientmember 141 can be configured to support output transducer 130 such thatoutput transducer 130 is coupled to the tympanic membrane TM when themedial ear canal assembly 100, including retention structure 110 isplaced in the ear canal EC. The resilient member 141 can be attached tothe stiff support 121, such that the resilient member 141 directlyengages the stiff support 121. The stiff support 121 can be affixed tothe resilient member 141 so as to position the umbo pad 136 below theretention structure 110, such that the umbo pad 136 engages the tympanicmembrane TM when the retention structure 110 is placed, for example onthe tympanic membrane annulus TMA. The resilient member 141 can beconfigured to provide a predetermined force to the eardrum when themedial ear canal assembly 100 is placed in the Ear Canal.

In the embodiments of FIGS. 5A and 5B, resilient member 141 may comprisea resilient cantilever beam. In these embodiments, photodetector 150 maybe attached to the output transducer 130 with a mount 153. Photodetector150 and output transducer 130 can deflect together when the biasingstructure 149, for example a spacer, is adjusted to couple the outputtransducer 130 and the umbo pad 136 to the tympanic membrane TM.

Sulcus sensors 230 may be positioned on layer 115 of retention structure110 such that sulcus sensors 230 are in contact with the tympanicmembrane TM and/or other portions of the ear canal EC when medial earcanal assembly 100 is positioned in the ear canal. Sulcus sensors 230may also be positioned on sulcus flanges 235 to optimize their positionin ear canal EC, such as, for example, to optimize their positionagainst the tissue of tympanic membrane TM and/or against the tissue ofthe tympanic membrane annulus TMA. Sulcus flanges 235 may be used to,for example, position sulcus sensors 230 over regions of highly vasculartissue in the ear canal EC, such as on the tympanic membrane TM. Sulcusflanges 235 may be used to, for example, position sulcus sensors 230over the pars tensa.

FIG. 6 shows an isometric view of the medial ear canal assembly 100.Medial ear canal assembly 100 comprises a retention structure 110, asupport structure 120, a transducer 130, at least one spring 140 and aphotodetector 150. Medial ear canal assembly 100 may include dataprocessor 200 and transmitter 210 which may be positioned on transducer130. Medial ear canal assembly 100 may further include non-contactsensors 260 and tethered sensors 250. Non-contact sensors 260 andtethered sensors 250 may be connected to data processor 200 to providedata to data processor 200. Alternatively, or in combination, one ormore of data processor 200, transmitter 210, non-contact sensor(s) 260and tethered sensors 250 may be part of, located on, or connected toelectronics package 215 on photodetector 150. Tethered sensors 250 maybe positioned against the skin SK in the ear canal EC where umbo sensors220 (not shown in FIG. 6) and sulcus sensors 230 (not shown in FIG. 6)cannot contact. Alternatively or in combination, one or more ofnon-contact sensors 260 may be positioned loosely in ear canal EC togather data. Retention structure 110 is sized to couple to the tympanicmembrane annulus TMA and at least a portion of the anterior sulcus AS ofthe ear canal EC. With respect to the remaining elements of theretention structure and their function, see the discussion of FIGS. 2and 3.

FIG. 7 shows and isometric view of the medial ear canal assembly 100including retention structure 110, support structure 120, springs 140, aphotodetector 150, and at least one drug delivery device. In embodimentsof the invention, medial ear canal assembly 100 may include reservoir400 and delivery tube 410 which are adapted to deliver drugs to thewearer. In embodiments of the invention, reservoir 400 may be used tostore drugs for delivery to, for example, the tympanic membrane. Inembodiments of the invention, delivery tube 410 may be used to transportdrugs from reservoir 400 to umbo pad 136 which may be constructed totransmit the drugs to or through at least a portion of the tympanicmembrane TM. In embodiments of the invention, umbo pad 136 may beconstructed to include, for example, microneedles through which drugsmay be transported into the tissue of, for example, the tympanicmembrane.

In embodiments of the invention, the medial ear canal assembly 100 mayinclude sensors, such as, for example, umbo sensors 220, sulcus sensors230 and tethered sensors 250, such as those shown in FIGS. 4, 5, and 6.In embodiments of the invention, sensors located on medial ear canalassembly 100 may be used to collect data on the user, which user datamay be used to regulate the flow of drugs from the at least one drugdelivery device which is incorporated into medial ear canal assembly100. In embodiments of the invention, the drug delivery device on medialear canal assembly 100 may include power supply 426 adapted to providepower to medial ear canal assembly 100, including pump 424.

FIG. 7A is an isometric view of the medial ear canal assembly 100including retention structure 110, a photodetector 150, and at least onedrug delivery device. In embodiments of the invention, medial ear canalassembly 100 may include reservoir (not shown) and delivery tube 410which are adapted to deliver drugs to the wearer. In embodiments of theinvention, the reservoir may be used to store drugs for delivery to, forexample, the tympanic membrane or the region surrounding the tympanicmembrane. In embodiments of the invention, delivery tube 410 may be usedto transport drugs from the reservoir to umbo pad 136 which may beconstructed to transmit the drugs to or through at least a portion ofthe tympanic membrane TM. In embodiments of the invention, umbo pad 136may be constructed to include, for example, microneedles 422 throughwhich drugs may be transported into the tissue of, for example, thetympanic membrane. In embodiments of the invention, umbo pad 136 may beconstructed to include, for example, needles 420 through which drugs maybe transported into the tissue of, for example, the tympanic membrane.In embodiments of the invention, retention structure 110 may beconstructed to include, for example, microneedles 422 through whichdrugs may be transported into the tissue of, for example, the tympanicmembrane. In embodiments of the invention, the drug delivery device onmedial ear canal assembly 100 may include pump 424 adapted to pump drugsfrom the reservoir to microneedles 422. In embodiments of the invention,the drug delivery device on medial ear canal assembly 100 may includepump 424 adapted to pump drugs from the reservoir to needle 420. Inembodiments of the invention, the drug delivery device on medial earcanal assembly 100 may include power supply 426 adapted to provide powerto medial ear canal assembly 100, including pump 424.

FIG. 8 shows a lateral ear canal assembly 12, including a retentionstructure 310 (which may also be referred to as an eartip retentionstructure) configured for placement in the ear canal. Retentionstructure 310 may comprise a molded tubular structure having the shapeof the ear canal. Retention structure 310 may be configured to retainlateral ear canal assembly 12 in the ear canal. Lateral ear canalassembly 12 may include a signal source 320 such as a laser diode. Anouter surface 340 of retention structure 310 may include ear tip sensors240, which may be positioned against the skin SK of the ear canal ECand, alternatively or in combination, sensors (not shown) which arepositioned on the medial or lateral ends of lateral ear canal assembly12, such as, for example, a body temperature sensor.

FIG. 9 is an isometric Top view of a medial ear canal assembly inaccordance with embodiments of the present invention. In FIG. 9, medialear canal assembly 100 comprises transducer 130, photodetector 150,spring 140, support structure 120 and retention structure 110. In theembodiment of FIG. 9, sulcus sensors 230 may be positioned on retentionstructure 110, which may be, for example a flexible material adapted toconform to the anatomy of the user's ear canal. Retention structure 110may comprise a material such as Parylene or Silicone.

FIG. 10 is an isometric bottom view of a medial ear canal assembly inaccordance with embodiments of the present invention. In FIG. 10, medialear canal assembly 100 may comprise transducer 130, photodetector 150,spring 140, support structure 120, retention structure 110 and umbo pad136. In the embodiment of FIG. 10, sulcus sensors 230 may be positionedon retention structure 110, which may be, for example a flexiblematerial adapted to conform to the anatomy of the user's ear canal. Inthe embodiment of FIG. 10, umbo sensors 220 may be positioned on umbopad 136. Retention structure 110 may comprise a material such asParylene or Silicone.

In embodiments of the invention, umbo sensors 220, sulcus sensors 230,eartip sensors 240, and tethered sensors 250 may comprise sensors thatcontact the skin to detect biometric data. Alternatively, or incombination, umbo sensors 220, sulcus sensors 230, eartip sensors 240,and tethered sensors 250 may comprise sensors that do not require skincontact to detect biometric data. Non-contact sensors may also besensors which do not require skin contact to detect biometric data.

Skin contacting sensors adaptable for use in embodiments of the presentinvention may include: micro-sensors, electrochemical sensors; thin filmsensors; pressure sensors; micro-needle sensors, capacitive sensorsthermometers, thermocouples, trigeminal nerve monitors; piezoelectricsensors; electrodes, pulse oximetry sensors, glucose meters, oxygensensors and iontophoresis electrodes.

Non-skin contacting sensors adaptable for use in embodiments of thepresent invention may include: light sensors (e.g. optical sensors orinfrared sensors); sound sensors (e.g. a microphone to pick up sounds inthe ear canal); vibration sensors; heat sensors, micro-sensors;electrochemical sensors; thin film sensors; liquid (e.g. oil) sensors;accelerometers, microphones; gyroscopes, including 3-axisaccelerometers, 3 axis gyroscopes; MEMS sensors, including 3 axis MEMSsensors; GPS circuitry; pedometers; reservoir monitors; walking gaitsensors; battery state monitors; energy level monitors; and straingauges.

In embodiments of the present invention, a suitable microphone might betransducer 130 wired to measure back electromagnetic fields (back EMF)which is generated when post 134 is moved independent of any drivesignal provided to transducer 130, such as by vibrations in the tympanicmembrane TM resulting from, for example the user speaking or snoring.The back EMF could then be provided to data processor 200 where it couldbe analyzed and transmitted to a receiver in lateral ear canal assembly12 or in a remote receiver (e.g. a smart phone) by transmitter 210. Inone embodiment of the invention, data processor 200 could includecircuitry used to separate sounds coming from sources other than theuser from sounds generated by the user to provide filtered data, whichfiltered feedback data may represent, for example, the user's voice.

In embodiments of the invention, a suitable optical sensor may comprisean infrared transmitter and infrared receiver. In embodiments of theinvention, a suitable optical sensor may include an optical receivertuned to the same frequency as signal source 320.

In embodiments of the invention, sensors may be 3D printed on or as anintegral part of structures in the components of hearing system 10. Inembodiments of the invention, non-skin contacting sensors may be mountedon, for example, the back side of photodetector 150.

In embodiments of the invention, a light may be mounted on medial earcanal assembly 100 and positioned to shine through tympanic membrane TMto illuminate the middle ear and the contents thereof. In embodiments ofthe invention, a sensor may be further included on medial ear canalassembly 100 to measure light reflected from the middle ear.

In embodiments of the invention, sensors on medial ear canal assembly100 may be used to sense the position of transducer assembly withrespect to structural features of the ear canal EC, such as the tympanicmembrane TM. The data from such sensors may be used to position themedial ear canal assembly 100 to ensure it is properly placed andaligned in the user's ear.

In embodiments of the invention, sensors on medial ear canal assembly100 or positioned in the ear canal EC may be used to measureenvironmental factors which are related to the proper functioning of themedial ear canal assembly 100, such as, degradation in photodetectoroutput, earwax buildup, whether the user is compliant with the requiredoiling regimine. In embodiments of the invention, sensors may be used toensure that the user is properly oiling by, for example, measuring theamount and regularity of oiling. In embodiments of the invention,sensors on the eartip may be used to guide and/or detect proper medialear canal assembly insertion. In embodiments of the invention, pressuresensors and/or fluid sensors may be positioned on a medial ear canalassembly, including on the umbo pad 136 or sulcus platform to assist inthe preceding tasks.

In embodiments of the invention, strain gauges may be included in themedial ear canal assembly 100 to provide feedback on the properplacement of medial ear canal assembly 100. For example, post 134 mayinclude strain gauges which indicate when displacement starts and/or thedegree of displacement by registering the lateral force on umbo pad 136.Further, the placement of one or more strain gages on retentionstructure 110 may provide an indication that the medial ear canalassembly 100 has lifted off of the tympanic membrane TM. In embodimentsof the invention, medial ear canal assembly 100 may include featureswhich interact with physical features of the wearer to maintain medialear canal assembly 100 in a predetermined position in the ear canal EC,such as, for example against the tympanic membrane TM. In embodiments ofthe invention, such physical features may create strain on the medialear canal assembly 100, which strain may be measured by strain gaugespositioned on medial ear canal assembly 100 to ensure proper placementof medial ear canal assembly 100.

In embodiments of the invention, a feedback signal representative of theaverage power received by photodetector 150 may be provided, whichsignal may be used to quantify the coupling efficiency betweenphotodetector 150 and signal source 320. In embodiments of theinvention, the power level of signal source 320 may be adjusted toreflect the degree of coupling and the coupling efficiency indicated bythe feedback signal. In embodiments of the invention, the position oflateral ear canal assembly 12 and/or medial ear canal assembly 100 maybe modified to increase or decrease the level of the feedback signal,thus improving the coupling efficiency between the lateral ear canalassembly 12 and the medial ear canal assembly 100.

In embodiments of the invention, noise cancelation may be implementedby, for example, incorporating a microphone onto the back ofphotodetector 150. Sound signals received by the microphone could beconverted into drive signals which move the tympanic membrane inopposition to the received signals such that the received signals arenot perceived by the user. Such noise cancelation may be implementedsuch that the microphone is turned on only when the output from thephotodetector exceeds a predetermined voltage, such as, for example,approximately 300 millivolts. Alternatively, or in combination, themicrophone may be turned on when the photodetector output voltageexceeds approximately 1 volt. In one embodiment of the invention, thesound signals may be measured by measuring the back EMF of transducer130 and generating a signal to the transducer which causes thetransducer to vibrate the tympanic membrane in a way which cancels themovement which generated the measured back EMF.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measurebodily fluids, such as sweat, interstitial fluid, blood and/or cerumen(ear wax). Sensors suitable for making these measurements includeelectrochemical sensors, micro-needles and capacitive sensors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measuresweat for the purpose of, for example, measuring hydration levels,electrolyte balance, lactate threshold, glucose levels, calories burned,respiration rate, drug levels, metabolites, small molecules (e.g. aminoacids, DHEA, cortisol, pH levels and various proteins. Sensors suitablefor making these measurements include electrochemical sensors,micro-needles and capacitive sensors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measurethe temperature, including the core body temperature of a user. Sensorssuitable for making these measurements include thermometers,thermocouples, and optical temperature sensors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor blood pressure, blood flow, heart rate, pulse, andarrhythmia. Sensors suitable for making these measurements includeelectrodes, PPG (Photoplethysmography) sensors and pulse oximetrysensors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor the oxygen level in a user's blood. Sensors suitable formaking these measurements include optical sensors PPG(Photoplethysmography) sensors, and/or pulse oximetry sensors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor drug delivery and/or medication use by monitoring thedrug content in blood or interstitial fluid of a user. Sensors suitablefor making these measurements include micro-needles and/or iontophoresiselectrodes.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor body fat. Sensors suitable for making these measurementsinclude electrodes.

Physical Monitoring

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to monitorand/or measure sleep, including the duration and/or quality of suchsleep. Sensors suitable for making these measurements includeaccelerometers, microphones and gyroscopes.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor snoring and/or sleep apnea. Sensors suitable for makingthese measurements include accelerometers, microphones; gyroscopes; headposition monitors (3 axis gyroscope); vibration sensor (microphone, TMTmicroactuator); oxygen sensors; and trigeminal nerve monitors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC and/or on the tympanicmembrane may be used to measure and/or monitor the location of a user.Sensors suitable for making these measurements include GPS circuitry.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor the movement of a user. Sensors suitable for making thesemeasurements include an accelerometer and/or a pedometer.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor calorie intake. Sensors suitable for making thesemeasurements include microphones and piezoelectric sensors.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor posture, head position and/or body position. Sensorssuitable for making these measurements include gyroscopes,accelerometers (including 3-axis accelerometers) and MEMS sensors(including 3 axis MEMS sensors).

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor seizure disorders, including epilepsy, by makingelectroencephalogram (EEG) measurements. Sensors suitable for makingthese measurements include electrodes and/or electroencephalograph.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor electrical activities of the heart by making anelectrocardiogram (ECG/EKG). Sensors suitable for making thesemeasurements may include electrodes and/or electrocardiographs.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor the electrical activity produced by skeletal muscles bymaking an electromyogram using Electromyography (EMG). Sensors suitablefor making these measurements may include electrodes and/orelectromyographs.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor the glucose in a user's blood and/or interstitial fluid.Sensors suitable for making these measurements include glucose meters,electrochemical sensors, microneedles, and/or iontophoresis electrodes.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor neurological function. Sensors suitable for making thesemeasurements may include sensors for measuring the walking gait of auser.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to measureand/or monitor the position and/or orientation of a user's eye.

Many other physical characteristics may be measured by sensors on medialear canal assembly 100 or positioned in the ear canal EC, including:multi-axis acceleration; multi-axis angle; skin capacitance; infraredabsorption, (e.g. pulse ox), chemical reactions; and strains.

In embodiments of the present invention, devices on medial ear canalassembly 100 or positioned in the ear canal EC may be used to delivermedication to a user. Devices suitable for making these delivers mayinclude drug reservoirs, patches, microneedles, polymers designed toelute over time and/or drug eluting materials.

In embodiments of the invention, drugs may be delivered through, forexample, iontophoresis, direct skin contact, needles, drugs in theplatform, drug infused silicon or other structural materials or holes orpores in the tympanic membrane structure to hold drugs prior todispensing or weep over time.

In embodiments of the present invention, devices on medial ear canalassembly 100 or positioned in the ear canal EC may be used to stimulateserotonin production in a user by, for example, shining light in the earcanal EC for predetermined periods of time. Alternatively, such devicesmay be adapted to increase the production of vitamin D.

In embodiments of the present invention, devices, including sensors onmedial ear canal assembly 100 or positioned in the ear canal EC may beused to recognize the speech of a user. Devices suitable for makingthese delivers may include microphones and speech recognition/signalprocessing chips and software.

In embodiments of the present invention, sensors on medial ear canalassembly 100 or positioned in the ear canal EC may be used to controlthe function of hearing system 10. The function of hearing system 10 maybe controlled by, for example, sensing control instructions from theuser, including, verbal instructions and/or instructions conveyed byfinger snapping, bone conduction and/or bringing a hand or finger intoproximity with the sensors on medial ear canal assembly 100. Sensorssuitable for such control functions may include touch sensors, boneconduction sensors and proximity sensors.

In embodiments of the present invention, the power required to operatesensors, drug delivery, and/or other devices located on medial ear canalassembly 100 may be supplied by one or more of the following: AC or DCcurrent from photodetector 150; AC or DC current from an RF antennalocated on or connected to medial ear canal assembly 100; Energy from abattery, micro-battery and/or super capacitor on or connected to medialear canal assembly 100. In further embodiments of the present invention,circuitry on medial canal assembly 100 may be obtained by, for example:harvesting power from the motion of the user, including the dynamicmotion of the wall of an outer ear, using, for example, a spring locatedon or connected to medial ear canal assembly 100; harvesting power fromthe motion of the tympanic membrane, including harvesting sound energywhich vibrates the tympanic membrane; harvesting power from the motionof the tympanic membrane, including harvesting sound energy belowapproximately 100 Hz; harvesting power from the action of muscles in ornear the ear canal, such as, for example muscles used in chewing food;harvesting power from the temporomandibular joint; using the movement ofthe eardrum (such as, for example, driven by music) to act as a pump. Inembodiments of the invention circuitry on medial ear canal assembly 100may be powered by, for example, the use of light based earplugs whichtransmits energy to medial ear canal assembly 100 to power the assemblywhen lateral ear canal assembly 12 is not being used. In embodiments ofthe invention, such light based earplugs may be used to rechargebatteries or super capacitors located on or connected to medial earcanal assembly 100. In embodiments of the invention circuitry on medialear canal assembly 100 may be powered by, for example, a wand whichradiates, for example, RF energy to an antenna located on or connectedto medial ear canal assembly 100 to power sensors on medial ear canalassembly 100 and/or in the ear canal EC for the purpose of makingmeasurements.

In embodiments of the present invention, sensors located on medial earcanal assembly 100 may communicate data to any one of a number ofdevices, including lateral ear canal assembly 12, a smartphone, a smartwatch, a cellular network, a ZigBee network, a Wi-Fi network, a WiGi-Gnetwork, and/or a Bluetooth enabled device. In embodiments of thepresent invention, such information may be transmitted from medial earcanal assembly 100 to lateral ear canal assembly 12 and from lateral earcanal assembly 12 to a smartphone, a smart watch, a cellular network, aZigBee network, and/or a Bluetooth enabled device. In embodiments of theinvention, such sensors a part of a closed loop communication network.In embodiments of the invention, communication to medial ear canalassembly 100 may be facilitated by the positioning of an antenna on orconnected to medial ear canal assembly 100. In embodiments of theinvention, such antennas may be printed on or formed as part of achassis of medial ear canal assembly 100. In embodiments of the presentinvention, communication of data may be facilitated by the inclusion oftransmitter 210 on medial ear canal assembly 100.

In embodiments of the invention, removable portions of hearing system 10may sense emergency situations, such as fire alarms, and communicatewith the user wearing medial ear canal assembly 100 using an antennalocated on or connected to medial ear canal assembly 100 to warn theuser of danger.

In embodiments of the invention, data collected from sensors located onmedial ear canal assembly 100 or in the ear canal EC of a user may becommunicated to the user's physician and/or family. In embodiments ofthe invention, data collected from sensors located on medial ear canalassembly 100 or in the ear canal EC of a user may be used to generatedata or reports which may be communicated to the user's physician and/orfamily. In embodiments of the present invention, information, data orreports which may be communicated to the user, the user's physicianand/or family may include information on the user's environment,including time of day, activity, surrounding sounds. In embodiments ofthe present invention, information, data or reports which may becommunicated to the user, the user's family physician, and/or family mayinclude information on biometric date related to the user, includingblood pressure, heart rate, glucose levels, and other biometric data. Inembodiments of the present invention, information, data or reports whichmay be communicated to the user, the user's family physician and/orfamily may include information on specific events related to the user orthe user's physical condition, including, falls, blood pressure spikes,heart attacks, temperature spikes, impending or actual seizures, changesin specific biomarkers, or other metrics. In embodiments of the presentinvention, information, data or reports which may be communicated to theuser, the user's family physician and/or family may include algorithmresults transmitted when trends or parameters in the user's biometricdata become concerning. In embodiments of the present invention,information, including warnings may be communicated to the user mayinclude, sleep apnea warnings, drowsiness warnings (e.g. when driving),warnings of impending seizures, migraine headaches warnings, and/orcluster headache warnings.

In embodiments of the invention, medial ear canal assembly 100 may beused to communicate with the user to, for example, remind the user whento drink or when the user's sugar levels are spiking or dropping.

In embodiments of the present invention, data or other information maybe transmitted by a user to the hearing system 10 of a second user. Inembodiments of the invention, a user may transmit data or otherinformation to a network of hearing systems 10.

In embodiments of the present invention, data collected by sensorspositioned on medial ear canal assembly 100 or in the ear canal of auser may be collected and analyzed, by, for example, an Application onthe user's smart phone. Such data may be used for many purposes,including predicating changes in the user's health and generating eventalarms.

Event alarms generated from the collected data might include alarmsrelated to epilepsy seizures, migraines, cluster headaches, orpredetermined changes in key biometric data or trends. Such data may befurther processed to allow the user to, for example, view the data whichis most important to the user, perform trend analysis on the data,correlate specific data with activities or environment, provide adashboard of data or chart specific data. Data may also be stored forreview at future doctor's appointments. Data trends may also be storedand analyzed over time.

Embodiments of the present invention are directed to a hearing systemcomprising a medial ear canal assembly including a transducer configuredto be positioned on the tympanic membrane of a user; a lateral ear canalassembly including a signal source configured to be positioned in theear canal of a user; and sensors connected to the medial ear canalassembly, the sensors being connected to a transmitter. In embodimentsof the invention, the sensors may include sensors adapted to detectbiometric data. In embodiments of the invention, the sensors may includesensors adapted to detect one or more physical characteristics of theuser. In embodiments of the invention, at least one of the sensors maycomprise a microphone. In embodiments of the invention, the microphonemay comprise a micro-actuator. In embodiments of the invention, soundreceived by the micro-actuator is configured to be converted to a backEMF signal. In embodiments of the invention, the hearing system mayinclude a data processor which is configured to convert the back EMF toa signal representative of the sound received by the micro-actuator. Inembodiments of the invention the hearing system may be configured totransmit the signal representative of the sound received by themicroactuator to a receiver external to the hearing system. Inembodiments of the invention, the receiver comprises a smart phone, awireless network, or a peripheral device. In embodiments of theinvention, at least one of the sensors comprises a skin contactingsensor or a non-skin contacting sensor. In embodiments of the invention,at least one of the sensors comprises an umbo sensor, an eartip sensor,or a tethered sensor.

Embodiments of the present invention are directed to a method of sensingphysical characteristics of a hearing system user, the hearing systemcomprising a medial ear canal assembly positioned on or near thetympanic membrane, the medial ear canal assembly comprising transducersensors and a transmitter, the method comprising the steps of: using thesensors to measure biometric data of the user; and transmitting themeasured biometric data using the transmitter. In embodiments of theinvention the method further comprising using the sensors to measure oneor more physical characteristics of the user. In embodiments of theinvention at least one of the sensors comprises a microphone the methodfurther comprising the steps of measuring sound in the user's ear canal.In embodiments of the invention the microphone comprises amicro-actuator, the method further comprising measuring the back EMFsignal. In embodiments of the invention the hearing system includes adata processor, the method further including the step of converting theback EMF signal to an electrical signal and transmitting the electricalsignal to the data signal processor. In embodiments of the invention theback EMF signal includes a first signal portion representative of thesignal received from the hearing system and a second signalrepresentative of at least one physical characteristic of the user, themethod further including the step of separating the first signal fromthe second signal. In embodiments of the invention the method furtherincludes the step of transmitting the signal to a receiver external tothe hearing system. In embodiments of the invention the receivercomprises a smart phone. In embodiments of the invention at least one ofthe sensors comprises a skin contacting sensor or a non-skin contactingsensor. In embodiments of the invention at least one of the sensorscomprises an umbo sensor, an eartip sensor, or a tethered sensor. Inembodiments of the invention the output transducer is used as a sensor.In embodiments of the invention the sensor is used as a microphone tomeasure received sound at the tympanic membrane. In embodiments of theinvention the signal from the microphone is coupled to the transmitter.

Embodiments of the present invention are directed to an ear canalplatform comprising: a medial ear canal assembly positioned on or overthe tympanic membrane of a user; and sensors connected to the signaloutput transducer, the sensors being connected to a transmitter. Inembodiments of the invention the sensors include sensors adapted todetect biometric data. In embodiments of the invention the sensorsinclude sensors adapted to detect one or more physical characteristicsof the user. In embodiments of the invention at least one of the sensorscomprises a microphone. In embodiments of the invention the microphonecomprises a micro-actuator. In embodiments of the invention soundreceived by the micro-actuator is configured to be converted to avoltage representative of the back EMF generated in the microactuator bythe sound received by the microactuator. In embodiments of the inventionthe hearing system includes a data processor which is configured toconvert the voltage to a signal representative of the sound received bythe micro-actuator. In embodiments of the invention the signal isconfigured to be transmitted by the hearing system to a receiverexternal to the hearing system. In embodiments of the invention thereceiver comprises a smart phone, a wireless network, or a peripheraldevice. In embodiments of the invention at least one of the sensorscomprises a skin contacting sensor or a non-skin contacting sensor. Inembodiments of the invention at least one of the sensors comprises anumbo sensor, an eartip sensor, or a tethered sensor.

Embodiments of the present invention are directed to a method of sensingphysical characteristics of a user having a medial ear canal assemblypositioned on or near the tympanic membrane, the medial ear canalassembly comprising sensors and a transmitter, the method comprising thesteps of: using the sensors to measure biometric data of the user; andtransmitting the measured biometric data using the transmitter. Inembodiments of the invention the method further comprising using thesensors to measure one or more physical characteristics of the user. Inembodiments of the invention at least one of the sensors comprises amicrophone the method further comprising the steps of measuring sound inthe user's ear canal. In embodiments of the invention the microphonecomprises a micro-actuator, the method further comprising measuring andtransmitting the output of the microphone. In embodiments of theinvention the hearing system includes a data processor, the methodfurther including the step of sending the transmitted signal to the dataprocessor. the transmitted signal includes a first signal portionrepresentative of the signal received from the hearing system and asecond signal representative of a physical characteristic of the user,the method further including the step of separating the first signalfrom the second signal. In embodiments of the invention the methodfurther includes the step of transmitting the signal to a receiverexternal to the hearing system. In embodiments of the invention thereceiver comprises a smart phone. In embodiments of the invention atleast one of the sensors comprises a skin contacting sensor or anon-skin contacting sensor. In embodiments of the invention at least oneof the sensors comprises an umbo sensor, an eartip sensor, or a tetheredsensor. In embodiments of the invention the output transducer is used asa sensor. In embodiments of the invention the sensor is used as amicrophone to measure received sound at the tympanic membrane. Inembodiments of the invention the signal from the microphone is coupledto the transmitter.

Embodiments of the present invention are directed to an ear canalplatform comprising: a medial ear canal assembly positioned on thetympanic membrane of a user; a drug delivery device mounted on the earcanal assembly. In embodiments of the invention an ear canal assemblyfurther includes sensors connected to the ear canal assembly, thesensors being connected to a transmitter. In embodiments of theinvention the sensors include sensors adapted to detect biometric data.In embodiments of the invention the sensors include sensors adapted todetect one or more physical characteristics of the user. In embodimentsof the invention at least one of the sensors is a microphone. Inembodiments of the invention the microphone is a micro-actuator. Inembodiments of the invention sound received by the micro-actuator isconverted to a transmitted signal. In embodiments of the invention thehearing system includes a data processor which converts the transmittedsignal to a signal representative of the sound received by themicro-actuator. In embodiments of the invention the signal istransmitted by the hearing system to a receiver external to the hearingsystem. In embodiments of the invention the receiver is a smart phone, awireless network, or a peripheral device. In embodiments of theinvention at least one of the sensors comprises a skin contactingsensor, or a non-skin contacting sensor. In embodiments of the inventionat least one of the sensors comprises an umbo sensor, an eartip sensor,or a tethered sensor.

Embodiments of the present invention are directed to a method ofdelivering drugs to a user having a medial ear canal assembly positionedon or near the user's tympanic membrane, the medial ear canal assemblycomprising a drug delivery device, the method comprising the steps of:delivering drugs to the user through the drug delivery device. Inembodiments of the invention the medial ear canal assembly furtherincludes sensors and a transmitter, the method comprising the steps of:using the sensors to measure biometric data of the user; andtransmitting the measured biometric data using the transmitter. Inembodiments of the invention the method further includes the step ofactivating the drug delivery device using the biometric data measured bythe sensors. In embodiments of the invention the method furthercomprises using the sensors to measure one or more physicalcharacteristics of the user. In embodiments of the invention the methodfurther comprises the step of activating the drug delivery device usingthe measured physical characteristics of the user. In embodiments of theinvention, the step of activating drug delivery includes activating drugdelivery when needed and/or at predetermined times or over predeterminedtime periods. In embodiments of the invention at least one of thesensors comprises a skin contacting sensor or a non-skin contactingsensor. In embodiments of the invention at least one of the sensorscomprises an umbo sensor, an eartip sensor, or a tethered sensor. Inembodiments of the invention, the system may comprise a reservoir andmechanisms for drug delivery.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the present inventiveconcepts. Modification or combinations of the above-describedassemblies, other embodiments, configurations, and methods for carryingout the invention, and variations of aspects of the invention that areobvious to those of skill in the art are intended to be within the scopeof the claims. In addition, where this application has listed the stepsof a method or procedure in a specific order, it may be possible, oreven expedient in certain circumstances, to change the order in whichsome steps are performed, and it is intended that the particular stepsof the method or procedure claim set forth hereinbelow not be construedas being order-specific unless such order specificity is expresslystated in the claim.

What we claim is:
 1. An ear canal platform comprising: a medial earcanal assembly adapted to be positioned on the tympanic membrane of auser, the medial ear canal assembly comprising a retention structureadapted to conform to the anatomy of the user's ear canal, wherein theretention structure includes a first end corresponding to a shapeprofile of the anterior sulcus and the anterior portion of the tympanicmembrane annulus; and a drug delivery device mounted on the ear canalassembly.
 2. An ear canal platform according to claim 1, furtherincluding sensors connected to the ear canal assembly, the sensors beingconnected to a transmitter.
 3. An ear canal platform according to claim2, wherein the sensors include sensors adapted to detect biometric data.4. An ear canal platform according to claim 3, wherein the sensorsinclude sensors adapted to detect one or more physical characteristicsof the user.
 5. An ear canal platform according to claim 2, wherein atleast one of the sensors is a microphone.
 6. An ear canal platformaccording to claim 5, wherein the microphone is a micro-actuator.
 7. Anear canal platform according to claim 6, wherein sound received by themicro-actuator is converted to a transmitted signal.
 8. An ear canalplatform according to claim 7, wherein the ear canal platform includes adata processor which converts the transmitted signal to a signalrepresentative of the sound received by the micro-actuator.
 9. An earcanal platform according to claim 8, wherein the signal is transmittedby a hearing system to a receiver external to the hearing system.
 10. Anear canal platform according to claim 9, wherein the receiver is a smartphone, a wireless network, or a peripheral device.
 11. An ear canalplatform according to claim 2, wherein at least one of the sensorscomprises a skin contacting sensor or a non-skin contacting sensor. 12.An ear canal platform according to claim 2, wherein at least one of thesensors comprises an umbo sensor, an eartip sensor, or a tetheredsensor.
 13. A method of delivering drugs to a user having a medial earcanal assembly positioned on the user's tympanic membrane, the medialear canal assembly comprising a drug delivery device and a retentionstructure adapted to conform to the anatomy of the user's ear canal,wherein the retention structure includes a first end corresponding to ashape profile of the anterior sulcus and the anterior portion of thetympanic membrane annulus, the method comprising the steps of:delivering drugs to the user through the drug delivery device.
 14. Amethod according to claim 13, wherein the medial ear canal assemblyfurther includes sensors and a transmitter, the method comprising thesteps of: using the sensors to measure biometric data of the user; andtransmitting the measured biometric data using the transmitter.
 15. Amethod according to claim 14, further including the step of activatingthe drug delivery device using the biometric data measured by thesensors.
 16. A method according to claim 14, the method furthercomprising using the sensors to measure one or more physicalcharacteristics of the user.
 17. A method according to claim 15, furthercomprising the step of activating the drug delivery device using themeasured physical characteristics of the user.
 18. A method according toclaim 14, wherein at least one of the sensors comprises a skincontacting sensor or a non-skin contacting sensor.
 19. A methodaccording to claim 14, wherein at least one of the sensors comprises anumbo sensor, an eartip sensor, or a tethered sensor.